BioMerieux VIDAS TPSA Diagnostic Recalled for Unauthorized Distribution
BioMerieux SA is recalling 1,902 units of VIDAS TPSA in vitro diagnostic tests because the product is not approved or authorized for distribution in the US.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity level when no specific injuries or illnesses are reported in the source text.
Plain-English summary
BioMerieux SA is recalling 1,902 units of VIDAS TPSA, an in vitro diagnostic device used for the automated quantitative measurement of prostate specific antigen levels in human serum or plasma. The recall is being conducted because the product is not approved or authorized for distribution in the United States.
The affected units are identified by Lot 1001904130. The product was distributed in Florida, Louisiana, Michigan, Mississippi, Nevada, Ohio, Oklahoma, Tennessee, and Texas.
Consumers and healthcare facilities should stop using the affected product and contact BioMerieux SA for further instructions.
The recalled product
- Product
- VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.
- Manufacturer
- BioMerieux SA
- Affected units
- 1,902
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 1001904130
Distribution
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